Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice

The investigators will test the impact of a decision aid, Head CT Choice, to determine if its use improves parents' knowledge and engagement in decision making and safely decreases healthcare utilization in children presenting to the emergency department with blunt head trauma.

Study Overview

• Status: Completed
• Conditions: Head Injury
• Intervention / Treatment: Other: Head CT Decision Aid

Detailed Description

The investigators' long term goal is to promote evidence-based, patient-centered evaluation in the acute setting, to more closely tailor testing to disease risk. The investigators will compare the use of risk stratification tools with usual clinical approaches to treatment selection or administration through the following aim:

Test if the decision aid, Head CT Choice, improves validated patient-centered outcome measures and safely decreases healthcare utilization. The investigators will randomize at the clinician level. Through the use of the intervention, Head CT Choice, the investigators aim to significantly increase parents' knowledge, engagement, and satisfaction, decrease the rate of head CT use, and decrease 7-day total healthcare utilization, with no significant increase in adverse events.

• Study Type: Interventional
• Enrollment (Actual): 971
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California, Davis Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota Masonic Children's Hospital
    • Minneapolis, Minnesota, United States, 55404
      • Children's Hospitals and Clinics of MN, Minneapolis
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
    • Saint Paul, Minnesota, United States, 55102
      • Children's Hospitals and Clincis of MN, St Paul ED
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Parents and their child, seeking care for a child who:

1. Is < 18 years of age;
2. Had blunt trauma above the eyebrows (not isolated to face or eyes);
3. Is positive for at least 1 of the PECARN clinical prediction rule predictors described below:

PECARN Predictors for children < 2 years of age:

Severe mechanism (PECARN definition)* Loss of consciousness > 5 seconds Acting abnormally per parent Initial ED GCS < 15 by attending (or CT decision-maker) Other signs of altered mental status (PECARN definition) Presence of occipital, temporal or parietal scalp hematoma Palpable skull fracture or unclear if skull fracture

PECARN predictors for children 2-18 years of age:

Severe mechanism (PECARN definition)* Any loss of consciousness Any vomiting since the injury Severe headache in ED Initial ED GCS < 15 by attending (or CT decision-maker) Other signs of altered mental status (PECARN definition)** Any sign of basilar skull fracture Clinicians include attending physicians and fellows or midlevel providers caring for children with head trauma

Exclusion Criteria:

Parents of children with:

1. GCS scores < 15
2. Evidence of penetrating trauma, signs of basilar skull fracture, or depressed skull fracture on physical examination
3. Brain tumors
4. Ventricular shunts
5. Bleeding disorder
6. Pre-existing neurological disorders complicating assessment
7. Neuroimaging at an outside hospital before transfer
8. Signs of altered mental status (agitation, somnolence, repetitive questioning, or slow response to verbal communication)
9. Syncope or seizure disorder preceded (led to) head trauma or seizure post head trauma
10. Known to be pregnant
11. Communication barriers such as visual or hearing impairment that may preclude use of the decision aid.
12. Strong suspicion of abuse for this head injury

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Decision Aid; Head CT Decision Aid	Other: Head CT Decision Aid; The decision aid, Head CT Choice, educates parents regarding how the clinician determined the severity of their child's head trauma, their child's quantitative risk for a clinically-important TBI, the pros and cons of cranial CT compared to active observation, and what signs and symptoms parents should watch for in the next 24 hours that should prompt a return visit to the ED.
NO_INTERVENTION: Usual Care; Clinicians and patients do not have access to the Head CT Decision Aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess Parents' Knowledge Regarding Their Child's Risk for a Significant Brain Injury	Knowledge will be measured by means of a post visit survey delivered immediately after the clinical encounter in the emergency department. The investigators will assess parents' knowledge regarding their child's quantitative risk for a significant brain injury, the pros and cons of head CT compared to active observation, and what signs and symptoms parents should watch for in the next 24-48 hours that should prompt a return visit to the ED. Each knowledge question will provide the parent(s) with three options to respond (True, False, or Unsure), and the parent(s) will receive a score of 1 for a correct response and 0 for an incorrect response and any response of 'Unsure' will be considered incorrect. An overall score will be calculated by summing the correct responses and dividing by the number of questions asked.	Day 1 (immediately after the clinical encounter)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Engagement in the Decision-making Process	Using the OPTION validated scale, the investigators will measure the degree to which clinicians engage parents' in the decision making process. The OPTION scale will be assessed by having 2 observers independently review and score the video recordings of the encounter between the parent and the child's emergency department clinician. The OPTION scale is composed of 12 items with a value of 0-4; they are summed, divided by 48 and multiplied by 100. This creates a score that ranges from 0-100, where higher scores are reflective of a higher level of parental engagement.	Day 1 (during the ED visit)
Decisional Conflict	The investigators will measure the degree of conflict patients experience related to feeling uninformed using the validated Decisional Conflict Scale (DCS). The 16 items of DCS are scored on a 0-4 scale; the items are summed, divided by 16 and then multiplied by 25. The scale is from 0-100 where higher scores are reflective of parental uncertainty about the choice.	Day 1 (immediately after the clinical encounter)
Trust in the Physician	The investigators will measure parents' trust in their clinician using the validated Trust in Physician Scale (TPS). There are 9 items with a scale of 1-5, the items are subtracted by 1, summed, divided by 9 and then multiplied by 25. The scale ranges from 0-100 where higher values are reflective of higher levels of trust in their physician.	Day 1 (immediately after the clinical encounter)
Parental Satisfaction	The investigators will assess parents' satisfaction by comparing the number of patients who reported being "strongly satisfied" with their choice.	Day 1 (immediately after the clinical encounter)
Proportion of Children Who Undergo Head CT	The study coordinator will ascertain whether the child underwent head CT in real time and confirm the data by health record review.	Day 1 (anytime during the index emergency department visit)
Healthcare Utilization - Number of Tests Ordered Within 7 Days	The investigators will assess healthcare utilization for the subsequent 7-days after the ED visit. Healthcare utilization will include measures such as hospitalization, re-hospitalization, primary and specialty visits, and diagnostics including CT use which will be obtained via a health record review, review of itemized hospital charges on the UB-92 and UB-04 forms (summary billing statements), and parental report via the 7 day follow-up by the study coordinator. Outcomes are reported as number of tests or procedures per patient, categorized based on the Berenson-Eggers Types of Service (BETOS) codes.	7-days
Rate of Clinically Important Traumatic Brain Injury (ciTBI)	The investigators will assess safety by comparing the rate of ciTBI in each arm of the study. The investigators will define ciTBI as we did in the original PECARN study: death from TBI, intubation for more than 24 hours for TBI, neurosurgical procedure, or hospital admission of 2 nights or more associated with TBI on CT.	7-days
Fidelity - Options for Care	We will measure the degree to which the intervention is implemented as intended in both intervention and control groups when reviewing the recordings. The recordings in the intervention group will serve as a measure of the fidelity with which the intervention was delivered as intended. We will use a checklist of elements present and absent for quantification of implementation.	Day 1

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Patient-Centered Outcomes Research Institute; Columbia University; Boston Children's Hospital; University of California, Davis; Nationwide Children's Hospital; Children's Hospitals and Clinics of Minnesota; University of Minnesota Masonic Children's Hospital; Flying Buttress Associates
• Investigators: Principal Investigator: M.Fernanda Bellolio, MD, Mayo Clinic

Publications and helpful links

General Publications

• Kuppermann N, Holmes JF, Dayan PS, Hoyle JD Jr, Atabaki SM, Holubkov R, Nadel FM, Monroe D, Stanley RM, Borgialli DA, Badawy MK, Schunk JE, Quayle KS, Mahajan P, Lichenstein R, Lillis KA, Tunik MG, Jacobs ES, Callahan JM, Gorelick MH, Glass TF, Lee LK, Bachman MC, Cooper A, Powell EC, Gerardi MJ, Melville KA, Muizelaar JP, Wisner DH, Zuspan SJ, Dean JM, Wootton-Gorges SL; Pediatric Emergency Care Applied Research Network (PECARN). Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study. Lancet. 2009 Oct 3;374(9696):1160-70. doi: 10.1016/S0140-6736(09)61558-0. Epub 2009 Sep 14. Erratum In: Lancet. 2014 Jan 25;383(9914):308.
• Hess EP, Homme JL, Kharbanda AB, Tzimenatos L, Louie JP, Cohen DM, Nigrovic LE, Westphal JJ, Shah ND, Inselman J, Ferrara MJ, Herrin J, Montori VM, Kuppermann N. Effect of the Head Computed Tomography Choice Decision Aid in Parents of Children With Minor Head Trauma: A Cluster Randomized Trial. JAMA Netw Open. 2018 Sep 7;1(5):e182430. doi: 10.1001/jamanetworkopen.2018.2430.
• Hess EP, Wyatt KD, Kharbanda AB, Louie JP, Dayan PS, Tzimenatos L, Wootton-Gorges SL, Homme JL, Pencille R N L, LeBlanc A, Westphal JJ, Shepel K, Shah ND, Branda M, Herrin J, Montori VM, Kuppermann N. Effectiveness of the head CT choice decision aid in parents of children with minor head trauma: study protocol for a multicenter randomized trial. Trials. 2014 Jun 25;15:253. doi: 10.1186/1745-6215-15-253.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: February 13, 2014
• First Submitted That Met QC Criteria: February 13, 2014
• First Posted (ESTIMATE): February 14, 2014

Study Record Updates

• Last Update Posted (ACTUAL): May 9, 2019
• Last Update Submitted That Met QC Criteria: May 8, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Pediatric; Emergency Department; Shared Decision Making; Decision Aids; Head Injury; Head CT
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Craniocerebral Trauma
• Other Study ID Numbers: 13-004659; FP00071515 (OTHER: PCORI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO